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Safety, Tolerability & Pharmacokinetics Study of CNTX-6016 in Healthy Subjects and Subjects With PDN | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Safety, Tolerability & Pharmacokinetics Study of CNTX-6016 in Healthy Subjects and Subjects With PDN

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CNTX-6016 in Healthy Subjects and a Single Cohort of Subjects With Painful Diabetic Neuropathy

NCT04857957•Centrexion Therapeutics

View on ClinicalTrials.gov

Summary

A Phase 1b study to evaluate the safety, tolerability and pharmacokinetics of multiple ascending doses of CNTX-6016 in healthy subjects and a single cohort to evaluate painful diabetic neuropathy.

Eligibility

Age

18 - 59 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Is in good general health as determined by Investigator's review.
•Has a body mass index (BMI) between 18 and 35 kg/m2.
•Non- or ex-smoker (\> 1 year) and has not used any nicotine containing products within 12 months prior to screening.
•For females, is not currently pregnant and is either of non-childbearing potential or willing to use an adequate method of birth control.
•For males, must agree to use barrier contraception and not to donate sperm
•A diagnosis/history of Type 2 diabetes mellitus
•The pain is present in both feet/legs with symmetrical onset
•The pain is characterized as burning, painful, cold or electrical shocks in nature
•The pain is associated with tingling, numbness, itching or pins and needles type sensations
•The pain has been present and consistent for ≥ 6 months

Exclusion Criteria

•Is pregnant, lactating, or planning a pregnancy during the study.
•Tests positive for COVID-19 after screening is complete and subject is confirmed to enroll
•History of or active cardiac disease, including congestive heart failure, angina, or any arrhythmia.
•Has any history or currently active type of cancer except excised or cured basal cell carcinoma.
•Has an immunological disorder such as, but not limited to, human immunodeficiency virus (HIV), acquired, or congenital immune deficiency syndrome; autoimmune diseases, such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, seronegative spondyloarthropathies or vasculitis, or any infection.
•Positive urine screen for alcohol, cotinine, THC and/or drugs of abuse
•Has positive screening test for hepatitis B virus (HBV) or hepatitis C virus (HCV).
•Diagnosis of Type 1 diabetes
•Has serious or unstable cardiovascular, hepatic, renal, respiratory or hematological illness
•Has a history or currently active type of cancer except excised or cured basal cell carcinoma.
+4 more criteria

Locations (1)

AltaSciences

Overland Park, Kansas, United States

Key Dates

Start Date

April 14, 2021

Primary Completion Date

August 30, 2023

Completion Date

August 30, 2023

Last Updated

July 28, 2025

Enrollment

ACTUAL participants

Conditions

Painful Diabetic Neuropathy

Interventions

Oral dose CNTX-6016 or oral dose Placebo

DRUG

Feasibility of Self-treatment of Painful Diabetic Neuropathy Using Electrical Vasomotor Nerve Stimulation

NCT06524284

Painful Diabetic Neuropathy

View study

COMPLETEDNA

Axon Therapy and Conventional Medical Management for Painful Diabetic Neuropathy Compared to Sham and Conventional Medical Management

NCT05620225

NeuralgiaNeuropathic Pain+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety, Tolerability & Pharmacokinetics Study of CNTX-6016 in Healthy Subjects and Subjects With PDN

Inclusion Criteria

Exclusion Criteria

Feasibility of Self-treatment of Painful Diabetic Neuropathy Using Electrical Vasomotor Nerve Stimulation

Axon Therapy and Conventional Medical Management for Painful Diabetic Neuropathy Compared to Sham and Conventional Medical Management

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